One of the more notable changes to take effect Jan. 22, 2019, with the Revised Common Rule is a significant expansion of the exemption categories. The changes will mean that many studies that require expedited status review under the current rule will qualify for exempt status. Chart review studies, including those that use data that has not yet been created at the time the study begins. and research involving “benign behavioral interventions” in particular will be more likely to qualify for exempt status reviews under the revised rule.
An annotated copy of the revised Exempt Status Review policy can be found here. Significant changes are highlighted, with some explanations added in the comments.
A few things to keep in mind about exempt status research:
- “Exempt” does not mean “entirely exempt from IRB oversight.” Exempt status studies still require IRB submissions through CLARA.
- If you will interact with subjects for your exempt status projects, you can expect to need an informed consent process for the research, even if you are not collecting signed consent forms. This requirement means the submission will require a description of the consent process, a copy of any written information or discussion outlines to be used during that process, and you’ll indicate on the new submission form that a consent process will occur but that you’re requesting a waiver of consent documentation (which is NOT the same thing as a waiver of the entire consent process).
- When exempt status studies involve protected health information, HIPAA is still applicable. HIPAA requirements mean you may need to request a waiver of the requirement to get a signed authorization form, or you’ll have to include some discussion of HIPAA in your consent process or get a signed form from subjects.